Silicone Gel Breast Implant Safety

Without a doubt, silicone gel breast implants have been the most controversial medical devices to ever hit the market in the United States. It has gone through years of scrutiny, testing, moratoriums, lawsuits, etc. However, study after study has found no link between silicone breast implants and autoimmune disorders, and in 2006, the FDA lifted the 14 year moratorium on these implants.

Silicon (not silicone) is the most abundant element on earth. It does not occur naturally in its pure metallic state. Silica in its crystalline form exists in sand, marble, or quartz. It also occurs in an amorphous form, and very fine, extremely pure, amorphous silica is used as a filler to strengthen solid silicone, such as in the shell of an implant (each grain of silica is encapsulated tightly in silicone so that even when the elastomer is abraded or torn, no silica is exposed to the body.)1

Dimethylsiloxane is the building block for most medical grade silicone products, including breast implants. It can be made extremely pure and modified into products with a multitude of characteristics.1

Silicone Breast Implant Safety FAQ

Are silicone gel breast implants safe?

Silicone gel breast implants have been around since 1962. Countless studies have been performed on these implants, and they have been deemed safe.

What are some of the studies that have been done on silicone gel breast implant safety?

Silicone breast implants have undergone decades of scrutiny and scientific studies.

National Cancer Institute (NCI)– This study involved 13,500 women that received silicone breast implants for cosmetic purposes. They were followed for a period of 13 years. The results of the study showed that silicone breast implants does not increase the risk of breast cancer, or most other types of cancers, aside from respiratory and brain cancers, although the significance of the increased risk is not clear. The study also found that women with breast implants are not at an increased risk for connective tissue disorders when their records were reviewed by two independent rheumatologists who did not know if the women had a silicone breast implant or not.

Institute of Medicine (IOM) – Evidence suggests that diseases or conditions are no more common in women with breast implants than in women without breast implants.

National Science Panel – No identifiable associations between the use of silicone and disease.

In October 1996, Judge Sam C. Pointer Jr., the coordinating judge for federal breast implants litigation, established the Rule 706 National Science Panel. The purpose of this panel was to investigate scientific data about breast implants and their possible relation to connective tissue disease and immune system dysfunction. The panel reviewed over 2,000 medical documents and heard testimony under oath from legal, medical, and scientific experts. The panel released their findings in November 1998, and concluded that there were no identifiable associations between the use of silicone breast implants and disease.

Independent Review Group (IRG) – No scientific evidence of an association between silicone gel-filled breast implants and any established connective tissue disorder.

The IRG on silicone breast implants was assembled by the Chief Medical Officer of the UK to review the possible health issues associated with silicone gel breast implants. Members of the IRG were selected for their independent views, their knowledge and understanding of the issues, and lack of any financial interest in the conclusions they reached.

Harvard Nurses Study – In this study, 87,501 nurses were studied, 1,183 of whom had silicone breast implants. The study followed these women from June 1976 through May 1990, before the avalanche of lawsuits over purported links between silicone breast implants and connective tissue disease.

The investigators found that women with implants were, if anything, slightly less likely to develop connective tissue diseases like rheumatoid arthritis, or even to complain of signs and symptoms of disease that resembled those of connective tissue diseases, but fell short of meeting the standard diagnostic criteria.

Swedish Cohort Study – The data on this study was based on Swedish women that received breast implants from 1965 to 1993. They were followed for almost 19 years. This study concluded that there is no support for the conjecture that breast implants cause neurological disease.

Silicone Studies by Implant Manufacturers

Adjunct Study

The largest study by breast implants companies was the Adjunct Study. In 1992, when FDA removed all silicone gel-filled breast implants from the market, the FDA continued to permit companies to provide the implants for reconstruction after mastectomy, correction of congenital deformities, or replacement of existing breast implants. Women who received silicone gel-filled breast implants for these purposes were enrolled in Adjunct Studies so that data about device performance and safety could be collected. Participant enrollment began in 1992 for Mentor and 1997 for Allergan.

As a condition of approval of silicone gel-filled breast implants in 2006, both manufacturers were required to close enrollment of new patients into the Adjunct Studies, but continue to follow study participants through their 5-year post-implant evaluations.

Read the informed consent for the Mentor Adjunct Study here.

Mentor Core Gel Study

The Core Gel Study was a small study conducted by Mentor beginning in the fall of 2000. There were a total of 1,000 subjects in this study, the purpose of the study being further investigation into the safety and effectiveness of Mentor’s silicone gel-filled breast implants. The study was a ten year study and provided compensation to the subjects as an incentive to complete all of their post-operative and follow-up appointments.

Read the informed consent for the Mentor Core Gel Study here.